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Comparison of data characterising the clinical effectiveness of the fluocinolone intravitreal implant (ILUVIEN) in patients with diabetic macular edema from the real world, non-interventional ICE-UK study and the FAME randomized controlled trials.

Research paper by Sarah E SE Holden, Barry B Kapik, Annette B AB Beiderbeck, Craig J CJ Currie

Indexed on: 21 Dec '18Published on: 21 Dec '18Published in: Current medical research and opinion



Abstract

To compare the effectiveness and safety of the fluocinolone acetonide (FAc) intravitreal implant between the observational Iluvien Clinical Evidence study in the United Kingdom (ICE-UK) and the Fluocinolone Acetonide in Diabetic Macular Edema (FAME) randomized controlled trials (RCTs) in people with diabetic macular edema (DME). NCT00344968. We selected patients randomized to receive 0.2 µg/day FAc insert (FAc treated eyes) or sham injection (control eyes) from the FAME RCTs, and patients' first FAc treated eye and non-FAc treated fellow (control) eye from the ICE-UK study. Outcomes included change in visual acuity (VA), central foveal thickness (CFT) and intraocular pressure (IOP). After 12 months follow-up, mean change in VA was 5.0 letters improvement (p < 0.001) and 1.6 letters improvement (p = 0.003) in FAME FAc treated and control eyes, and 3.8 letters (p = 0.012) and -2.1 letters (p = 0.056) in ICE-UK treated and control eyes. Mean change in CFT was -144 µm (p < 0.001) versus -72 µm (p < 0.001) in FAME FAc treated and control eyes and -113 µm (p < 0.001) versus -13 µm (p < 0.001) in ICE-UK treated and control eyes. For eyes with a follow-up of 12 months, 77 (22.3%) and 15 (8.6%) FAME FAc treated and control eyes and 25 (18.7%) and 6 (4.3%) ICE-UK treated and control eyes required emergent IOP-lowering therapy. Statistically significant improvements in VA 12 months after FAc implantation were observed in both the real-world study as well as in the RCTs. The improvement in VA and CFT in the RCTs was greater than in the real-world study; however, recruits in the real-world study had more severe visual morbidity at baseline. Whilst there were many changes in the care of people with DME over this time, these data all support the value of treatment with FAc intravitreal implant.